Over-the-counter Availability and Regulatory Status

Progestin-only emergency contraception

Both Plan B One-Step® and Next Choice® are approved by the Food and Drug Administration (FDA) for sale without a prescription to women and men aged 17 years or older in the United States. A government-issued identification is required for proof of age to purchase Plan B One-Step and Next Choice without a prescription.1,2 Some women who are 17 and older need a prescription for progestin-only EC for insurance coverage (private or public) or because they do not have proper identification (i.e., undocumented immigrant status). Insurance coverage and immigration status are important access issues in some underserved communities.

Patients can go to the Emergency Contraception Web Site for a list of health providers offering ECP:

www.not-2-late.org

Although most women can obtain progestin-only ECPs without a prescription, female patients aged 16 years or younger still need a prescription from a health care professional. The progestin-only EC over-the-counter (OTC) status for patients 17 years or older and prescription-only status for female patients younger than 17 years or women without proper identification (so-called dual-label status of these products) necessitates keeping progestin-only ECPs behind the counter in pharmacies. The FDA wanted patients to have access to a knowledgeable health care provider who could answer questions patients might have when purchasing ECPs. Therefore, the products may be shipped to and stocked only by pharmacies or clinics. They are not available at general retail locations that do not employ a licensed health care provider.

In pharmacy-access states, specially trained pharmacists can prescribe progestin-only ECPs when medically appropriate to female patients of any age, including those who do not have government-issued identification for proof of age. Currently, the pharmacy-access states include Alaska, California, Hawaii, New Hampshire, New Mexico, Massachusetts, Maine, Vermont, and Washington.3

The American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and Society for Adolescent Medicine have all supported the availability and use of EC in teens.4 Studies show that adolescents are capable of using ECPs correctly and safely and that access to EC is not associated with increased rates of unprotected intercourse, decreased use of condoms, or higher rates of pregnancy or sexually transmitted infections.4-6 If not in a pharmacy access state, pharmacists can help female patients younger than 17 years old obtain ECPs by offering a list of local clinicians and clinics that provide prescriptions for ECPs.

Because most adult patients now have unfettered access to progestin-only ECPs through OTC availability, access to these products has increased. Pharmacies also lower access barriers by not requiring appointments; being open evenings, weekends, and holidays; and offering progestin-only OTC EC to both women and men who meet the age requirement.

Of important note, patients seeking EC are not subject to the same requirements as patients seeking pseudoephedrine and other potential methamphetamine precursors; purchasers of EC do not need to sign a registry in the pharmacy, and no limits exist for the maximum quantity that can be purchased. Similar to the sale of OTC nicotine products, the sale of progestin-only EC is limited only by the age of the purchaser, with no requirement for record keeping of purchases.

Ulipristal acetate emergency contraception

In contrast with progestin-only emergency contraception, ulipristal acetate (ella®) does not have OTC availability; all women, regardless of their age, require a prescription to obtain the product. Of the nine pharmacy access states, only Washington State has current legislation that allows pharmacists to prescribe ulipristal acetate (UPA) EC. The relevant legislation in the other eight pharmacy access states requires expansion or rewording to include the prescribing of ulipristal acetate.

Pharmacists in all direct access states should review their state laws with regard to restriction of EC prescribing to determine whether they can prescribe UPA. Based on the wording of the state's legislation, UPA may or may not be included under the term "emergency contraception." If pharmacists determine that their state allows them to prescribe UPA, they should consult their state board of pharmacy regarding any changes that might be required, such as updating collaborative agreements, obtaining special certification, or filing a new protocol with the board.

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